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Late But Not Too Late | Submitting Post-Filing Data During Patent Prosecution in Selected Jurisdictions | Kilpatrick Townsend & Stockton LLP

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Intellectual Property counsel often face the dilemma of when to file a patent application: as soon as possible, or wait and gather more support? Filing an application “early” helps to avoid anticipatory prior art but if the application is filed too early, the applicant may risk rejections during examination for lack of supportive evidence.
On the other hand, if the application is filed too late, the applicant may lose the priority date. This is especially problematic for biopharma industry applicants where on one hand, these data are often critical for securing a patent; on the other hand, the research and development cycle is long and generating experimental and clinical trial data require significant resources and time to obtain, and business and financial reasons can also render it difficult to predict when the data will become available. Frequently supporting data and related information are not available ....

United States , United Kingdom , South Korea , Republic Of Korea , Marzone Chems , Chiteki Zaisan , Hoechst Marion Roussel , Eli Lilly , Energy Rentals Inc , European Patent Office , Yeda Research Development Co , Intas Pharmaceutical Ltd , Honble Delhi High Court , Supreme People Court , Trademark Office , Indian Patent Office , Japan Patent Office Examination Guidelines , Ajanta Pharma Ltd , Korean Intellectual Property Office , Eli Lilly Canada Inc , See Eli Lilly Co , Amgen Court , Kilpatrick Townsend Stockton , High Court , Allergan Inc , Patent Office ,

Bayer Healthcare LLC v. Baxalta Inc. (Fed. Cir. 2021) | McDonnell Boehnen Hulbert & Berghoff LLP

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Last week, the Federal Circuit affirmed a jury verdict against Baxalta Inc., Baxalta US Inc., and Nektar Therapeutics for infringing Bayer Healthcare s patent to human blood clotting factor conjugates in
Bayer Healthcare LLC v. Baxalta Inc.
Bayer Healthcare sued Defendants on U.S. Patent No. 9,364,520, alleging willful infringement by Baxalta s product, Adynovate®. This product is a recombinant human Factor VIII (the blood clotting factor responsible for causing Hemophilia A) having the protein structural domains A1-A2-B-A3-C1-C2, wherein the B portion was specifically modified by addition of polyethylene glycol (PEG). PEGylation is important because Factor VIII has an 11-hour half-life which requires frequent injections and leads to reduced patient compliance. The prior art had disclosed random modification of Factor VIII with PEG, which had several drawbacks due to the multiplicity of PEGylation ....

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